Aditi Singhai
Regulatory Intelligence Associate at Redica Systems- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
-
English Full professional proficiency
-
Hindi Native or bilingual proficiency
Topline Score
Bio
Erik Muegge, M.S.
Aditi has worked in my organization for a couple of years. She is a graduate from the Temple University Regulatory Affairs and Quality Assurance graduate program. This greatly helped her hit the ground running. Since then she has been involved in several key special initiatives that have a direct impact on both quality of the product we produce as well as a positive impact on processes. She supports the manufacturing of a highly complex medical device and is the final signatory to release the instrument for sale. We expected a lot from her when she was hired and she has delivered. She is sought out by peers as well as those we support, dives deep to understand a process, teaches others, and is driven to meet deadlines with quality work. It is a delight to work with her and our organization is stronger because of her.
Tanjina Islam (MS, MSc, CSSGB)
Aditi is a great team-player. Her attention to details is excellent. She's very skilled as a Operation Quality Specialist. I wish her good luck for future endeavors.
Erik Muegge, M.S.
Aditi has worked in my organization for a couple of years. She is a graduate from the Temple University Regulatory Affairs and Quality Assurance graduate program. This greatly helped her hit the ground running. Since then she has been involved in several key special initiatives that have a direct impact on both quality of the product we produce as well as a positive impact on processes. She supports the manufacturing of a highly complex medical device and is the final signatory to release the instrument for sale. We expected a lot from her when she was hired and she has delivered. She is sought out by peers as well as those we support, dives deep to understand a process, teaches others, and is driven to meet deadlines with quality work. It is a delight to work with her and our organization is stronger because of her.
Tanjina Islam (MS, MSc, CSSGB)
Aditi is a great team-player. Her attention to details is excellent. She's very skilled as a Operation Quality Specialist. I wish her good luck for future endeavors.
Erik Muegge, M.S.
Aditi has worked in my organization for a couple of years. She is a graduate from the Temple University Regulatory Affairs and Quality Assurance graduate program. This greatly helped her hit the ground running. Since then she has been involved in several key special initiatives that have a direct impact on both quality of the product we produce as well as a positive impact on processes. She supports the manufacturing of a highly complex medical device and is the final signatory to release the instrument for sale. We expected a lot from her when she was hired and she has delivered. She is sought out by peers as well as those we support, dives deep to understand a process, teaches others, and is driven to meet deadlines with quality work. It is a delight to work with her and our organization is stronger because of her.
Tanjina Islam (MS, MSc, CSSGB)
Aditi is a great team-player. Her attention to details is excellent. She's very skilled as a Operation Quality Specialist. I wish her good luck for future endeavors.
Erik Muegge, M.S.
Aditi has worked in my organization for a couple of years. She is a graduate from the Temple University Regulatory Affairs and Quality Assurance graduate program. This greatly helped her hit the ground running. Since then she has been involved in several key special initiatives that have a direct impact on both quality of the product we produce as well as a positive impact on processes. She supports the manufacturing of a highly complex medical device and is the final signatory to release the instrument for sale. We expected a lot from her when she was hired and she has delivered. She is sought out by peers as well as those we support, dives deep to understand a process, teaches others, and is driven to meet deadlines with quality work. It is a delight to work with her and our organization is stronger because of her.
Tanjina Islam (MS, MSc, CSSGB)
Aditi is a great team-player. Her attention to details is excellent. She's very skilled as a Operation Quality Specialist. I wish her good luck for future endeavors.
Credentials
-
ASQ Certified Quality Improvement Associate
ASQ - World HeadquartersJun, 2022- Oct, 2024
Experience
-
Redica Systems
-
United States
-
Information Services
-
1 - 100 Employee
-
Regulatory Intelligence Associate
-
Dec 2021 - Present
- Execute global regulatory intelligence activities, such as monitoring, acquiring, tracking, and categorizing information pertaining to the changing global regulatory landscape within the Life Science industry. - Engage in shaping the automation, tools, and processes supporting regulatory intelligence operations. - Analyze large datasets relevant to quality and compliance - Lead process improvement initiatives and create internal QA procedures to ensure correct, complete and… Show more - Execute global regulatory intelligence activities, such as monitoring, acquiring, tracking, and categorizing information pertaining to the changing global regulatory landscape within the Life Science industry. - Engage in shaping the automation, tools, and processes supporting regulatory intelligence operations. - Analyze large datasets relevant to quality and compliance - Lead process improvement initiatives and create internal QA procedures to ensure correct, complete and usable data is presented to the customers - Collaborate with cross-functional teams to ensure completion of assigned projects such as creation of new internal tools to streamline processes - Use Kaizen tools for continuous improvement of procedures and reducing our turn around time for publishing Reg Intel signals Show less - Execute global regulatory intelligence activities, such as monitoring, acquiring, tracking, and categorizing information pertaining to the changing global regulatory landscape within the Life Science industry. - Engage in shaping the automation, tools, and processes supporting regulatory intelligence operations. - Analyze large datasets relevant to quality and compliance - Lead process improvement initiatives and create internal QA procedures to ensure correct, complete and… Show more - Execute global regulatory intelligence activities, such as monitoring, acquiring, tracking, and categorizing information pertaining to the changing global regulatory landscape within the Life Science industry. - Engage in shaping the automation, tools, and processes supporting regulatory intelligence operations. - Analyze large datasets relevant to quality and compliance - Lead process improvement initiatives and create internal QA procedures to ensure correct, complete and usable data is presented to the customers - Collaborate with cross-functional teams to ensure completion of assigned projects such as creation of new internal tools to streamline processes - Use Kaizen tools for continuous improvement of procedures and reducing our turn around time for publishing Reg Intel signals Show less
-
-
-
Circle Cardiovascular Imaging
-
Canada
-
Software Development
-
100 - 200 Employee
-
Regulatory Affairs Specialist
-
Jun 2021 - Dec 2021
• Prepare the submission documentation for regulatory clearance for worldwide product approvals and registrations with HC, USFDA, TGA, CDSCO and other regulatory agencies. • Ensure development and implementation of a strong Quality Management System • Initiate and process change controls, CAPAs and deviations • Conduct gap analysis between internal procedures and government regulations • Participate in the product/process risk management activities • Prepare the submission documentation for regulatory clearance for worldwide product approvals and registrations with HC, USFDA, TGA, CDSCO and other regulatory agencies. • Ensure development and implementation of a strong Quality Management System • Initiate and process change controls, CAPAs and deviations • Conduct gap analysis between internal procedures and government regulations • Participate in the product/process risk management activities
-
-
-
Abbott
-
United States
-
Hospitals and Health Care
-
700 & Above Employee
-
Operations quality specialist
-
Jun 2019 - May 2021
• Perform quality release of complex medical diagnostic devices • Review electronic device history records (eDHRs) and product related non-conformances to ensure compliance and warrant application of quality culture • Initiate quality records and implement corrective and preventive actions (CAPA) for procedural non-conformances • Interface directly with operations team and quality engineers to investigate non-conformances, provide quality compliance consultation to ensure application… Show more • Perform quality release of complex medical diagnostic devices • Review electronic device history records (eDHRs) and product related non-conformances to ensure compliance and warrant application of quality culture • Initiate quality records and implement corrective and preventive actions (CAPA) for procedural non-conformances • Interface directly with operations team and quality engineers to investigate non-conformances, provide quality compliance consultation to ensure application of good documentation practices (ALCOA principles) • Assess and approve documentation change procedures • Involved in audit readiness activities for internal and external audits including ISO and Medical Device Single Audit Program (MDSAP) • Change leader representing the team in Gemba walks with higher management, generated and tracked various lagging and leading indicators of team performance • Create VSM and process map for process optimization and to reduce cycle times Show less • Perform quality release of complex medical diagnostic devices • Review electronic device history records (eDHRs) and product related non-conformances to ensure compliance and warrant application of quality culture • Initiate quality records and implement corrective and preventive actions (CAPA) for procedural non-conformances • Interface directly with operations team and quality engineers to investigate non-conformances, provide quality compliance consultation to ensure application… Show more • Perform quality release of complex medical diagnostic devices • Review electronic device history records (eDHRs) and product related non-conformances to ensure compliance and warrant application of quality culture • Initiate quality records and implement corrective and preventive actions (CAPA) for procedural non-conformances • Interface directly with operations team and quality engineers to investigate non-conformances, provide quality compliance consultation to ensure application of good documentation practices (ALCOA principles) • Assess and approve documentation change procedures • Involved in audit readiness activities for internal and external audits including ISO and Medical Device Single Audit Program (MDSAP) • Change leader representing the team in Gemba walks with higher management, generated and tracked various lagging and leading indicators of team performance • Create VSM and process map for process optimization and to reduce cycle times Show less
-
-
-
Dr. Reddy's Laboratories
-
India
-
Pharmaceutical Manufacturing
-
700 & Above Employee
-
Scientist
-
Aug 2013 - Dec 2015
• Completed over 200 lab scale trials to rationalize the product formula and optimize the production steps of microspheres. • Conducted product characterization to help optimize the formulation and increased the yield by 25%. • Validated new equipment by performing their qualification (IQ, OQ, PQ), created equipment usage SOP and imparted training. • Assisted in internal audits of the laboratory for safety and quality compliance in lab. Formulated audit reports and implement… Show more • Completed over 200 lab scale trials to rationalize the product formula and optimize the production steps of microspheres. • Conducted product characterization to help optimize the formulation and increased the yield by 25%. • Validated new equipment by performing their qualification (IQ, OQ, PQ), created equipment usage SOP and imparted training. • Assisted in internal audits of the laboratory for safety and quality compliance in lab. Formulated audit reports and implement CAPA. • Worked with the Regulatory team to streamline the controlled correspondence documents and help draft replies to regulatory agencies such as USFDA. • Responsible for obtaining various licenses and maintain regulatory affairs documentation. • Created templates, tested and optimized the implementation of electronic lab notebook which resulted in improved data integrity and easier internal audits. • Prepared comprehensive batch data compilations to generate and analyze trends in data. Show less • Completed over 200 lab scale trials to rationalize the product formula and optimize the production steps of microspheres. • Conducted product characterization to help optimize the formulation and increased the yield by 25%. • Validated new equipment by performing their qualification (IQ, OQ, PQ), created equipment usage SOP and imparted training. • Assisted in internal audits of the laboratory for safety and quality compliance in lab. Formulated audit reports and implement… Show more • Completed over 200 lab scale trials to rationalize the product formula and optimize the production steps of microspheres. • Conducted product characterization to help optimize the formulation and increased the yield by 25%. • Validated new equipment by performing their qualification (IQ, OQ, PQ), created equipment usage SOP and imparted training. • Assisted in internal audits of the laboratory for safety and quality compliance in lab. Formulated audit reports and implement CAPA. • Worked with the Regulatory team to streamline the controlled correspondence documents and help draft replies to regulatory agencies such as USFDA. • Responsible for obtaining various licenses and maintain regulatory affairs documentation. • Created templates, tested and optimized the implementation of electronic lab notebook which resulted in improved data integrity and easier internal audits. • Prepared comprehensive batch data compilations to generate and analyze trends in data. Show less
-
-
-
Natoli Engineering Company, Inc.
-
United States
-
Industrial Machinery Manufacturing
-
100 - 200 Employee
-
Project Intern
-
Jun 2012 - Nov 2012
• Conducted experiments to finalize the correct ratio of excipients to be used, bisect lines, shapes of the tablet, tablet weights and processing parameters to make a robust tablet. • Used Design of Experiments software to randomize and determine the best combination of variables for the tablet manufacturing process. • Completed Thesis work on “Study the effect of Compression force, mixing time, type of bisect line on “Content Uniformity of scored lined Acetaminophen tablets”. • Conducted experiments to finalize the correct ratio of excipients to be used, bisect lines, shapes of the tablet, tablet weights and processing parameters to make a robust tablet. • Used Design of Experiments software to randomize and determine the best combination of variables for the tablet manufacturing process. • Completed Thesis work on “Study the effect of Compression force, mixing time, type of bisect line on “Content Uniformity of scored lined Acetaminophen tablets”.
-
-
Education
-
2018 - 2019
Temple University School of Pharmacy
Master's degree, Regulatory affairs and Quality Assurance -
2011 - 2013
Narsee Monjee Institute of Management Studies, Indore
Master's degree, Pharmaceutics -
2007 - 2011
Narsee Monjee Institute of Management Studies
Bachelor of Pharmacy (B.Pharm.) -
2001 - 2005
Gitanjali Devshala, Hyderabad
Community
